Glucotrack has announced the receipt of St Vincent’s Hospital Melbourne Human Research Ethics Committee’s (HREC) approval for a multi-centre clinical study of its continuous blood glucose monitor (CBGM) in type 1 and type 2 diabetic patients.
The single-arm, prospective study aims to assess the safety and performance of the device over a year, with potential extensions up to three years.
It is set to enrol up to 30 subjects needing intensive insulin therapy and glucose monitoring. With the approval in place, Glucotrack will notify Australia’s Therapeutic Goods Administration (TGA) before continuing with the enrolment process.
The implantation procedure for the first subjects is expected to take place by July 2025.
The CBGM is a long-term implantable system without a wearable component, tailored for continuous blood glucose monitoring for up to three years.
It claims to directly measure glucose from blood, offering real-time readings and aiming to eliminate the lag time associated with interstitial glucose measurements.
Australia’s University of Melbourne professor David O’Neal will act as the study's principal investigator and oversee the research, alongside associate professor Neale Cohen from the Baker Heart and Diabetes Institute.
The Glucotrack CBGM is limited by US federal law for investigational use only.
The device's features include three-year sensor longevity, the absence of an on-body wearable component, and minimal calibration requirements.
Glucotrack CEO and president Paul Goode said: “Securing this approval represents a major milestone for our clinical programme and builds on the successful completion of our first-in-human study earlier this year.
“This year-long study will provide critical insights into the long-term performance, safety, and reliability of our innovative technology, which is designed to address key challenges identified by people with diabetes – including the need for extended sensor life, elimination of on-body wearables, and the benefits of direct blood glucose measurement.”
The company designs, develops and commercialises technologies for diabetic people.
In February 2025, the company completed a first-in-human study with its CGM that directly measures glucose levels from a blood vessel.
